What’s Happening: An Update on HIV Drug Patents

13 Sep 2007

Abbott Abandons its U.S Patent Application for "Heat-Stable" Lopinavir/Ritonavir

An inspection of the U.S Patent and Trademark Office (USPTO) file wrapper for Abbott’s application on "Heat-Stable" Lopinavir/Ritonavir, which forms the priority application for the Indian and European patent applications that we opposed/filed observations against last month, shows that Abbott has abandoned its application. Abbott failed to respond to the USPTO’s examination report to restrict or make an election given that the application claims more than one invention. Unfortunately, as the U.S allows applicants to re-file applications, under what is known as a continuation application, it is highly likely that Abbott will re-file. For those of you who want to access the file wrapper it is application no. 10/650,178 (published as US 2005/0048112 A1).

The Mystery of the Atazanavir Patent in India

Press reports and a letter we have seen from the patent office suggest that the Indian patent application 805/MAS/1997 for Atazanavir, the base compound for the well-known HIV drug Atazanavir Sulfate (known as Reyataz when marketed by BMS), has been abandoned by the patent holder Novartis AG. At the same time reports also suggest that Novartis may have another application on Atazanavir.

What is interesting about the 805/MAS/1997 application is that it was not published under the new patent regime after the 2005 Patents Act, but was published in 1997. In fact, (thanks to Professor Bhaven Sampat, who retrieved the publications), records show that along with Atazanavir, several other pharmaceutical product patents were published prior to 21 January 2005, when the publications began under the new patent regime in India. This raises a number of questions about what is going on at the Indian Patent Office and whether there are a number of earlier publications that may have been missed by parties seeking to file oppositions.

As for Atazanavir, I-MAK has searched the nearly 200 Novartis patents published before 2005 to see if the application was filed in duplicate or whether a similar application existed with a different title. We haven’t found anything to suggest there is a duplicate patent for Atazanavir in India, but given the double entry of some patent applications we’re still looking.

Gilead has no patent protection for Tenofovir in South Africa, Namibia or ARIPO

After all the voluntary licenses handed out by Gilead for Tenofovir DF, we thought it would be interesting to see where Gilead actually has patent protection. Surprisingly, we found that Gilead does not have patents for Tenofovir Disoproxil or Tenofovir DF in key countries such as South Africa and Namibia, or even ARIPO (although information from the patent office in Namibia and ARIPO is not without disclaimers due to the manual searching of patents). It is interesting to note that Aspen, South Africa’s largest generic producer, struck a voluntary licensing deal with Gilead — knowing Gilead had no protection there. The lack of protection in these countries is probably one of the reasons why Gilead is refusing to drop its application in India – so that it can prevent companies like Cipla, who did not take a license – from exporting from India should an application be granted.

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